Avenda Health Treatment System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 30, 2020 Avenda Health, Inc. % Michael Billig Co-Founder and Chief Executive Officer Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose. California 95110 Re: K201687 Trade/Device Name: Avenda Health Treatment System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: June 19, 2020 Received: June 22, 2020 Dear Michael Billig: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201687 Device Name Avenda Health Treatment System #### Indications for Use (Describe) The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, orthopedics, pulmonology, radiology, adiology, and urology, at a wavelength of 980nm. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Notification K201687 ### GENERAL INFORMATION [807.92(a)(1)] #### Applicant: Avenda Health, Inc. 929 Colorado Avenue Santa Monica, CA 90401 USA Phone: 310-957-5202 #### Contact Person: Brittany Berry-Pusey, PhD Co-Founder and COO, Avenda Health, Inc. Phone: 310-957-5860 Email: brit@avendahealth.com #### Application Correspondent: Michael J. Billig Regulatory and Clinical Consultant to Avenda Health, Inc. Co-Founder and Chief Executive Officer, Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Office: 408-400-0856 Email: mjb@experiengroup.com #### Date Prepared: November 23, 2020 DEVICE INFORMATION [807.92(a)(2)] Trade Name: Avenda Health Treatment System Generic Name: Powered Laser Surgical Instrument Common Name: Focal Laser Therapy System Classification: 21 CFR\$878.4810, Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Product Code: GEX Regulatory Class: II {4}------------------------------------------------ ### PREDICATE DEVICE [807.92(a)(3)] Predicate Device: Clinical Laserthermia Systems AB Tranbergels Thermal Therapy System (K142216) Reference Predicate Device: Medtronic Navigation Inc. Visualase Thermal Therapy System (K181859) ### DEVICE DESCRIPTION [807.92(a)(4)] The Avenda Health Treatment System ("Treatment System") is a thermal laser ablation system that causes coagulation necrosis of soft tissue. The Treatment System consists of the capital system Workstation and the single use Laser Applicator Kit. The Workstation contains core system hardware and software, provides the System's touchscreen user interface (UI), and serves as a "hub" to facilitate the connectivity of other System components. The Laser Applicator Kit consists of two patient-contacting disposable components, the Laser Catheter, and the Thermal-Optical Probe ("TOP"), which facilitate delivery of laser energy and monitoring of temperature, respectively. The Treatment Monitoring Software, which operates on the Workstation, provides the UI for controlling the device, displays previously generated patient and treatment plan information for the procedure, and actively monitors the treatment progress during a procedure by displaying output from the TOP. The Treatment System is additionally used with an off-the-shelf accessory, the Tubing Set, which transports saline in a closed-loop system between the Workstation and Laser Catheter to provide cooling of the Laser Catheter. The Treatment System further includes an optional patient-contacting disposable accessory, the Multi-Channel Needle Guide ("MCG"), which may be used to attach an ultrasound probe to the Laser Catheter and TOP for enhanced visualization tracking, if desired. #### INDICATIONS FOR USE [807.92(a)(5)] The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, and urology, at a wavelength of 980nm. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(a)(6)] The proposed device has the same intended use as the predicate device and reference predicate device. All three devices are powered surgical laser systems, used in a similar range of surgical applications, which perform coagulation of soft tissue at comparable power and wavelengths that can be conducted under image visualization and guidance. The devices are furthermore similar in technological characteristics with respect to providing a similar range of tissue damage and thermal monitoring capabilities. While there are minor technological differences between the {5}------------------------------------------------ proposed and predicate device, particularly with respect to specific laser parameters, these differences do not raise any different questions of safety and effectiveness, as confirmed through the results of performance testing. The following table (Table 1) presents a tabular comparison of technological characteristics between the proposed device, predicate device, and reference predicate device. | Feature | Predicate Device | Reference Predicate<br>Device | Proposed Device | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Clinical Laserthermia<br>Systems AB.<br>TranbergCLS Thermal<br>Therapy System<br>(K142216) | Medtronic Navigation<br>Inc.<br>Visualase Thermal<br>Therapy System<br>(K181859) | Avenda Health Inc.<br>Avenda Health<br>Treatment System<br>(K________) | | Classification | 21 CFR§878.4810, Laser<br>Surgical Instrument for<br>Use in General and Plastic<br>Surgery and in<br>Dermatology | 21 CFR§878.4810, Laser<br>Surgical Instrument for<br>Use in General and Plastic<br>Surgery and in<br>Dermatology | Same | | Product Code | GEX | GEX, FRN, LLZ | GEX | | Intended<br>Use/Indications for Use | The TranbergCLS Thermal<br>Therapy System is<br>indicated for use in<br>surgical applications<br>requiring the ablation,<br>vaporization, excision,<br>incision, and coagulation<br>of soft tissue in areas of<br>surgery including:<br>gastroenterology, general<br>surgery, plastic surgery,<br>genitourinary (urology),<br>gynecology (GYN),<br>neurosurgery,<br>otolaryngology (ENT)<br>head and neck,<br>orthopedics,<br>ophthalmology,<br>pulmonology, and thoracic<br>surgery. | The Visualase™ Thermal<br>Therapy System is<br>indicated for use to<br>necrotize or coagulate soft<br>tissue through interstitial<br>irradiation or thermal<br>therapy under magnetic<br>resonance imaging (MRI)<br>guidance in medicine and<br>surgery in cardiovascular<br>thoracic surgery<br>(excluding the heart and<br>the vessels in the<br>pericardial sac),<br>dermatology,<br>ear-nose-throat surgery,<br>gastroenterology, general<br>surgery, gynecology, head<br>and neck surgery,<br>neurosurgery, plastic<br>surgery, orthopedics,<br>pulmonology, radiology,<br>and urology, for<br>wavelengths 800nm<br>through 1064nm.<br>When therapy is<br>performed under MRI<br>guidance, and when data<br>from compatible MRI | The Avenda Health<br>Treatment System is<br>indicated for use in<br>surgical applications<br>requiring the ablation,<br>vaporization, excision,<br>incision, and coagulation<br>of soft tissue in areas of<br>surgery including:<br>cardiovascular thoracic<br>surgery (excluding the<br>heart and the vessels in<br>the pericardial sac),<br>dermatology,<br>ear-nose-throat surgery,<br>gastroenterology, general<br>surgery, gynecology, head<br>and neck surgery,<br>neurosurgery, plastic<br>surgery, orthopedics,<br>pulmonology, radiology,<br>and urology, at a<br>wavelength of 980nm. | | Feature | Predicate Device | Reference Predicate<br>Device | Proposed Device | | | Clinical Laserthermia<br>Systems AB.<br>TranbergCLS Thermal<br>Therapy System<br>(K142216) | Medtronic Navigation<br>Inc.<br>Visualase Thermal<br>Therapy System<br>(K181859) | Avenda Health Inc.<br>Avenda Health<br>Treatment System<br>(K____) | | | | sequences is available, the<br>Visualase™ system can<br>process images using<br>proton<br>resonance-frequency<br>(PRF) shift analysis and<br>image subtraction to relate<br>changes in complex phase<br>angle back to relative<br>changes in tissue<br>temperature during<br>therapy. The image data<br>may be manipulated and<br>viewed in a number of<br>different ways, and the<br>values of data at certain<br>selected points may be<br>monitored and/or<br>displayed over time.<br>The Visualase™ Thermal<br>Therapy System is<br>compatible with General<br>Electric Medical Systems<br>Signa model MR scanners<br>and with Siemens Medical<br>Solutions Magnetom<br>Espree systems. When<br>interpreted by a trained<br>physician, this device<br>provides information that<br>may be useful in the<br>determination or<br>assessment of thermal<br>therapy. Patient<br>management decisions<br>should not be made solely<br>on the basis of<br>Visualase™ analysis. | | | Wavelength (Diode<br>laser generator) | 1064nm | 800nm – 1064nm | 980nm | | Output power | 1W - 25W at output port | 3W – 15W at output port | Up to 14W at output port | | Output power accuracy | ±10% of selected value | ±20% of selected value | ±20% of selected value | | Feature | Predicate Device | Reference Predicate<br>Device | Proposed Device | | | Clinical Laserthermia<br>Systems AB.<br>TranbergCLS Thermal<br>Therapy System<br>(K142216) | Medtronic Navigation<br>Inc.<br>Visualase Thermal<br>Therapy System<br>(K181859) | Avenda Health Inc.<br>Avenda Health<br>Treatment System<br>(K) | | Mode of operation | Continuous wave (CW) or<br>controlled by tissue<br>temperature monitored by<br>a temperature sensor | Continuous wave (CW),<br>pulsed, or external<br>modulation modes. | Continuous Wave (CW) | | Output power<br>increments | 1W | 0.5W | 0.1W | | Cooling | TEC | TEC | Same | | Channel(s) | 1 | 1 | Same | | Output port | SMA 905 | SMA 905 | Proprietary | | Aiming wavelength | 635nm | 650nm | 635 or 650nm | | Laser Type (per IEC<br>60825-1) | Class 4 | Class 4 | Same | | Laser Safety<br>Classification FDA | Class 2 | Class 2 | Same | | Power source (General) | 100-240V AC / 50-60Hz | 100-240V AC / 50-60Hz | 120V AC / 60Hz | | Operating temperature<br>range | 15°C - 28°C | 18°C - 35°C | 10°C - 33°C | | Emergency switch | Yes | Yes | Same | | Key activation of laser<br>output | Yes | Yes | Same | | Remote Interlock | Yes | Yes | Same | | Power ON/OFF visual<br>indicator | Yes | Yes | Same | | Laser emission<br>Indicator | Yes | Yes | Same | | Internal laser power<br>monitor | Yes | Yes | Same | | Manual reset | Yes | Yes | Same | | Fiber insertion interlock | Yes | Yes | Same | | Audio warning signal<br>level | Fixed at HIGH | HIGH, MEDIUM, LOW,<br>and OFF | Same as Predicate Device | | Pump-driven applicator<br>cooling | Yes | Yes…